Cameron Donahue
Management
Good afternoon, everyone. On behalf of Simulations Plus, I welcome you to our Fourth Quarter Fiscal Year 2020 Financial Results Conference Call and Webinar. Hosting the call today is Simulations Plus’ CEO, Shawn O’Connor; and the company’s CFO, John Kneisel. An opportunity to ask questions will follow today’s presentation. [Operator Instructions] Before beginning, I’d like to remind everyone that with the exception of historical information, the matters discussed in this presentation are forward-looking statements that involve numerous risks and uncertainties. The actual results of the company could differ materially from those statements. Factors that can cause or contribute to such differences include, but are not limited to, continued demand for the company’s products, competitive factors, the company’s ability to finance future growth, the company’s ability to produce and market new products in a timely fashion, the company’s ability to continue to attract and retain skilled personnel and the company’s ability to sustain or improve the current levels of productivity. Further information on the company’s risk is contained in the company’s quarterly and annual reports and filed with the Securities and Exchange Commission. With that said, I’d like to turn the call over to CEO, Shawn O’Connor. Shawn? Shawn O’Connor: Thank you, Cameron. Fiscal 2020 was a milestone year for Simulations Plus. We achieved all our stated goals. We accelerated organic revenue growth from the historical 10% level to our 15% to 20% target range. Overall, fiscal year 2020 total revenue growth was 22% and organic revenue growth excluding Lixoft was 18% for the year. This was achieved despite the disruption to our marketplace that came with the COVID pandemic. We’ve made a significant acquisition to expand our software business and grow our European presence. And we completed a strategic offering, giving the company resources in scale to pursue additional acquisitions, to further bolster our growth rates and broaden the value we can deliver to our clients. During the year, Simulations Plus continued to build upon its leadership position in modeling and simulation for the pharmaceutical drug development marketplace. In addition to the acquisition of the Monolix Suite product, we enhanced our portfolio of software offerings through internal development and launched several important collaborations with clients and regulatory agencies, furthering our relationship and advancing our technology. On the consulting side, we continued to broaden our service offerings and have grown our consulting team by approximately 22%. We continue to support clients and demonstrate the value of modeling and simulation to improve their drug development process. Modeling is increasingly important to the process, helping reduce costs, accelerate pipelines, and contribute to positive regulatory interactions. The pandemic has only heightened to reinforce this dynamic as the need to accelerate the delivery of therapeutic solutions has been highlighted, the increased use of modeling and simulation and the significant revenue and cost impact that they have four clients underlies our ability to grow revenues, customers and profitability into the future. For the year, we delivered revenue of $41.6 million, up 22% year-over-year, compared to 15% growth in the prior year. Organically excluding the impact of the Lixoft acquisition, revenue grew 18% year-over-year, compared to 15% organic growth in the prior year. Considering the impact of the pandemic, this is a strong result for the company. We achieved strong growth in both our software and consulting revenues. For the year, software revenues grew 16% to $21.6 million, compared to $18.5 million and growth of 9% last year. Organically software revenues were $20 million and grew 8% compared to $18.5 million and a growth rate of 9% last year. For the year, consulting revenues grew 30% to $20 million and compared to $15.5 million in growth of 21% last year. Turning to the fiscal 2020 fourth quarter revenue, total revenues grew 19% to $9.5 million, compared to $8 million and growth of 20% last year. Organically overall revenue grew 7% to $8.6 million, compared to last year’s fourth quarter. For the fourth quarter, software revenues grew 24% to $4.7 million, compared to $3.8 million and growth of 17% last year. Organically, software revenues were flat at $3.8 million compared to last year’s fourth quarter. For the fourth quarter, consulting revenues grew 14% to $4.8 million, compared to $4.2 million and growth of 23% in last year’s fourth quarter. As those of you who have followed this now, the fourth quarter is a seasonally our slowest revenue quarter for several reasons, including pharma software buying patterns and our license revenue recognition policy, as well as the impact of summertime client and consultant availability. In addition to these ongoing phenomenon, this year’s fourth quarter revenue growth was impacted as follows: four software clients reduced their licenses by about 25% from prior year levels because of acquisition, site consolidations and/or layoffs in their organizations. This impacted our software renewal rate for the quarter, which came in at 88%. From time to time, we experience this type of change in our installed base, but we do not expect this to impact our historical renewal rate which is about 93% going forward. In fact, despite this fourth quarter outcome, our software renewal rate for the year remained at 93%. Additionally, discussions are ongoing with three of these software clients and the potential for incremental module and/or collaboration business in their new budget year. Last year, we experienced some slippage of software renewals from Q3 to Q4. Clients that fully renewed but did not complete the process timely, resulting in sequential revenue growth last year of 4% and 17% in Q3 and Q4. This impacted the fourth quarter year-over-year growth rate this year with no real impact in annual revenue growth or renewals. New customer license growth has continued to be slowed down by COVID. However, these opportunities appear to be delayed, not lost, and we expect some level of pent-up demand as things normalize. On the consulting side, revenue sourced by our DILIsym QSP services began to accelerate late last year and peaked in the first quarter of this year at 138% growth. As a result of project timing and mix, these DILIsym QSP service revenues were down 4% in the fourth quarter compared to last year. Fiscal year 2020 full year growth for DILIsym QSP services was great at 42%. This quarter’s growth is reflective of the larger nature and timing of DILIsym QSP projects and resulting revenue recognition thereof. Our overall revenue growth expectations remain unchanged. I’ll speak later in the call about overall company-wide revenue growth expectations, which again remain unchanged. Let me speak to each of our software and consulting service segments. First, with regard to our software business. Our software revenues represented approximately 52% of total revenue compared to 55% last year. With a full year of Monolix Suite revenue, we expect software to move back to and perhaps above the 55%-plus level in fiscal year 2021. GastroPlus continues to serve as our flagship product and generates the largest individual portion of our software revenue. You can see the contributions of ADMET Predictor and the new contribution from Monolix Suite, which contributed only five months of revenue since we closed the acquisition in April. With a full year of revenue contribution in fiscal 2021, we anticipate Monolix Suite will contribute approximately 10% of our total revenue. During fiscal year 2020, we advanced the science and client value of our industry-leading PBPK and machine learning platforms and broadened our offerings with the acquisition of Monolix Suite. Today, we offer our clients leading modeling platforms across the spectrum of modeling techniques utilized in the drug development process. During the year, we entered into 12 R&D collaborations with the FDA and large pharma companies for enhancement of features and functionalities of our software. Such endeavors contribute significantly to the expansion of capabilities, increased use cases, which drive demand and solidify our standing with the regulatory bodies and our customers. Combined with our own R&D investment, we have maintained our leadership position for our modeling platforms. GastroPlus, GastroPlus remains well established as the leading PBPK modeling platform in the industry. We recently released GastroPlus version 9.8, which includes the industry’s first mechanistic model for intra-articular delivery and a revamped virtual bioequivalence trial simulation engine to address many of the requirements published in the FDA’s new regulatory guidance document on PBBM applications. ADMET Predictor, during September, we released version 10.0 of ADMET Predictor, which we will market as APX. Key enhancements in APX include: a new AIDD module for AI-driven drug design, using multi objective compound optimization integrated with physiologically based pharmacokinetic models; a new transporters module, containing machine learning models for pivotal transporters under regulatory guidance; significant improvements to the HTPK Simulation Module driven by our strategic collaboration with a large pharmaceutical partner; multi-threading capabilities for all prediction processes, including mechanistic HTPK simulations. The new AIDD module was released with APX is a separately priced module used with ADMET Predictor functionality. We also entered into a collaboration with a pharmaceutical company to evaluate and validate the new AIDD module. Our computational chemists work with the partners team to define the multi-objective parameters against which the lead molecules needed to be optimized. We’re pleased with the value demonstrated in this partnership to date. Monolix Suite, in October, we released Monolix Suite 2020R1 Amongst the new features included in this release is a new Simulex module. It is a powerful and flexible simulator for clinical trial pharmacometrics with an easy-to-use interface. In addition, it allows for a complete modeling and simulation workflow from data analysis and non-compartmental analysis to population modeling and simulation with fully interoperable applications. It provides users with a fast, easy-to-use and powerful suite of applications for pharmacometrics analysis, modeling and simulation. Integration with Lixoft has proceeded smoothly. All operations have been fully integrated, and this process went faster and more smoothly than we anticipated. We’re revamping collaboration between sales and marketing functions, including integrating Monolix Suite sales and marketing into the Simulations Plus infrastructure and training our consultants to use Monolix to facilitate future cross-selling. With regard to a few other key metrics for our software business, as previously commented upon, our fourth quarter renewal rate on fees were impacted by the four clients who reduced their renewals by about 25% and brought our metric down for the quarter to 88%. At the same time, we saw a lower-than-usual churn in our academic and non-profit accounts resulting in a higher renewal rate based upon accounts. For the year, we maintained our high renewal rate at 93% and expect this trend to continue into fiscal year 2021. During fiscal 2020, our new software license close rate was slowed, and this is reflected in our new customer metrics for the fourth quarter compared to last year. That said, we finished the full year with an increase in new software customers compared to the prior year. And when we focus on our commercial clients who contribute 94% of our software revenues, our net commercial software client count and revenue grew 16%. And our number of customers whose license value to us exceeds $100,000, grew 40%. Let me shift now to our consulting business. Our services revenue grew at 30% for the full year compared to 21% growth last year. For fiscal year 2020, our consulting revenues were sourced 23% of total revenues from PK/PD services, which are primarily delivered by Cognigen, 15% of our total revenues from QSP QST services delivered by DILIsym and 10% of our total revenues from PBPK services delivered primarily by our Lancaster group. Our consulting business continues to perform well with strong revenue growth and profitability. We support our clients’ use of modeling and simulation to positively impact their drug development programs through both the outsourcing of their modeling and simulation needs as well as in addressing specific issues encountered in development programs. We’re particularly pleased when we are able to contribute to regulatory achievements that advance special specific drug programs. Recent examples of this include: the FDA approval of Ubrogepant, in which DILIsym modeling predicted liver safety profile supporting its advanced to Phase 3 clinical trials and ultimate approval without labeling warnings where the first two drugs in class failed due to significant liver toxicity. The FDA approval of Pexidartinib, the first symptomatic therapy for treatment of symptomatic tenosynovial giant cell tumors, where DILIsym liver toxicity analysis supported its NDA. And finally, the inclusion of DILIsym liver safety analysis and the scientific review of the State of California Office of Environmental Health Hazard Assessment of Acetaminophen, these are but a few of the examples, which modeling and analysis as a simulation analysis is impacting our clients’ interactions with regulatory agencies. During fiscal 2020, we introduced two new service offerings. Regulatory Strategies headed up by Sandra Suarez-Sharp, who joined us after a long tenure with the FDA. The objective of these services is more strategic versus data analysis in assisting our clients on how to derisk and accelerate their interactions with global regulatory agencies. COVID Strategies, many of our clients have obviously focused their efforts on the development of potential therapies for COVID. During the past quarter, we were engaged in multiple discussions related to these programs and have recently closed several contracts in this area. And finally, we continue to grow our capacity to meet the needs of our clients. During fiscal year 2020, the consulting staff grew by approximately 22% in support of our project growth, and positioning us well for fiscal year 2021. We generated strong growth from each of our consulting sources. During the overall – driving the overall a 30% growth rate for our consulting businesses in fiscal year 2020, PK/PD consulting revenues grew 24% for the year. QSP QST consulting revenues grew 42% for the year, and PBPK consulting revenues grew 30% for the year. The diversification of our consulting revenue sources is important in smoothing consulting revenue fluctuations. And finally, our consulting backlog continues to exceed $10 million at the end of the year. While a slowdown of new contracts because of COVID prevented us from growing backlog in the year, we’re still well-positioned as we enter fiscal year 2021. Let me turn to our fiscal 2021 outlook. Our goal is to maintain fiscal year 2021 organic growth in the 15% to 20% range, in line with the 18% organic growth we delivered in fiscal year 2020. In fiscal year 2021, incremental Lixoft revenue could contribute an additional 3% to 5% of revenue growth on top of the organic growth. Any revenue contributed by acquisitions closed in fiscal year 2021 would as well be incremental to this. Certainly, the pandemic will continue to create headwinds as we enter fiscal year 2021. New software license customers and new consulting service contracts will continue to close at a slower than historical pace. We’re currently in the budgeting season for most of our clients, and we’ve observed and participated in their efforts, which have often included the reallocation of R&D spend to accommodate their ongoing investment in COVID-related therapies. We expect that this budgetary process, when complete, will provide some stability to programs that over recent times have been on hold awaiting decisions. We’re targeting software growth of 20% to 25%, up from the 16% in fiscal year 2020. This growth rate is based on the new version of 9.8 release of GastroPlus. And in fiscal 2021, we expect the release of version 10, which we will market as GPX. Additionally, ADMET Predictor growth which accelerated in fiscal year 2020 will carry momentum into fiscal year 2021 and have additional revenue opportunity with the new AIDD module. Monolix Suite is performing well and tracking to their 15% and 30% growth rates as anticipated in their earn-out agreement. We’re rolling out a modest price increase and changes in our discount policies. And finally, our focus on processing initiatives will help us accelerate software growth. Prior sales and marketing resource and infrastructure investments are now being focused on strategic sales initiatives that will provide benefits. On the consulting side, we anticipate growth rate in fiscal year – our growth rate in fiscal year 2020 of 30% to be in the 25% to 30% in fiscal 2021. We see continued demand across our services with PKPD and PBPK services remaining consistent. DILIsym demand is expected to settle into a more consistent delivery of project flow, but the growth rate in line with historical trends. Growth will continue to benefit from the continued success of our regulatory assistance offering and the COVID strategies program. Overall, I expect the accelerated growth we have delivered in fiscal 2020 to continue into fiscal year 2021. Finally, let me speak briefly to our M&A strategy. We are actively engaged in M&A efforts focused on a population of targets that we believe could add value to our growth [indiscernible] and serve value to our client base. The targets consists of both software entities that extend our modeling and simulation application offering portfolio and service opportunities, which provide new service capabilities and/or add to our service capacity and geographic coverage. We have been successful in our historical M&A efforts in large part due to our focus and rigor in evaluating acquisitions. We continue to adhere to strict acquisition criteria that include product and culture fit, enhancement of value to our clients and appropriate valuation and accretive characteristics. I’m pleased with the progress that we’ve made effort today and excited about the size and quality of the pipeline. That said, we plan to move methodically and cautiously with a goal of continuing our M&A successes, safeguarding shareholder capital and creating sustainable value. I’ll now turn the call over to John to review some detailed financial results. John?